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1、1EnsuringDrugQualityforPublicHealthTheImplementationBrendaUratani,Ph.D.AssistantCountryDirectorFDAChinaOffice,Beijing2OverviewChallengestoGlobalizationofDrugManufacturingFDA’sWorkinChinaGMPPrinciples:Issuesofthemostconcern3ChallengesSignificantdemandin
2、resourcesforinspectionsConsequencesofglobalization,includingmoreforeignmanufacturingandclinicaltrialssitesGreatercomplexityassociatedwithmanufacturingFDAconcernaboutthestateofindustrycomplianceandinsufficientinvestmentinmanufacturingandqualitysystems4F
3、DAInternationalEffortsFDAOverseasEfforts Long-TermGoalProductscomingtotheU.S.meetU.S.requirements.StrengthenedRegulatoryCounterpartsIndustryResponsibility:SupplyChainManagementatPointofManufacture,PointofExport,andWhenPresentedforImportation5FDAOversea
4、sPresence CurrentLocationsChinaIndiaLatinAmericaEuropeMiddleEast(2010)6FDA’sWorkinChina78FDAChinaOfficeIn-CountryStaffBeijingChrisHickey,OfficeDirectorMikeKravchuk,Deputy(device)BrendaUratani(drug)IreneChan(food)ShanghaiCharlesAhn(druginspection)BJMarc
5、iante(deviceinspection)GuangzhouDennisDoupnik(foodinspection)DennisHudson(foodinspection)FDA/SFDAAgreement:KeyProvisionsKeyProvisions:RegistrationofdesignateddrugsanddevicesJointTraining/CapacityBuildingGreater/MoreRapidInformationSharingGreaterAccesst
6、oFacilitiesProductIntegrity/Anti-counterfeitingStrengthenedFDA,SFDACollaborationUnderMultilateralAuspices9DrugsinChina:WhatHasFDADone?FDA-SFDACollaborationInspectionsEngagementofIndustryCapacity-Building10WhatIsChinaDoing?UpdatingStandards,MethodsRevis
7、ionofChinaCGMPWorkingtoImproveDrugAdverseEventReportingTrainingEliteGroupofInspectorsRe:InternationalStandardsAttemptingtoStrengthenDrugApplicationReviewProcessTakingMoreActiveRoleinInternationalStandard-SettingShiftingFocustoConductMorePre-ApprovalIns
8、pectionsUtilizingToolstoDetectCounterfeitingSupplyChain:DevelopingToolsandStandardsforTracking/Tracing11China’sRoleinDrugDevelopment:ChallengesforChinaNeedforRegulatoryReformUniformityofimplementationofCGMPacrossallprovincesRegulatoryAu
